FDA Inspection
M.e. Nikkiso Company Ltd.M.e. Nikkiso Company Ltd. – FDA Inspection, May 26, 2011
Record Details
This FDA Inspection record concerns M.e. Nikkiso Company Ltd., with an inspection on May 26, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- M.e. Nikkiso Company Ltd.
- Inspection Date
- May 26, 2011
- Product Type
- Devices
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ID · c8df6234-55ea-4c42-9dc6-959c43a4f477
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 728053
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of M.e. Nikkiso Company Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for M.e. Nikkiso Company Ltd.
- FDA Inspection 962521 - 2016-02-18
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